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Parvovirus H-1 (ParvOryx) in Patients With Metastatic Inoperable Pancreatic Cancer (ParvOryx02)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02653313
Recruitment Status : Completed
First Posted : January 12, 2016
Last Update Posted : March 18, 2019
Sponsor:
Information provided by (Responsible Party):
Oryx GmbH & Co. KG

Tracking Information
First Submitted Date  ICMJE December 4, 2015
First Posted Date  ICMJE January 12, 2016
Last Update Posted Date March 18, 2019
Study Start Date  ICMJE December 2015
Actual Primary Completion Date May 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 8, 2016)
  • Safety and tolerability of the IMP [ Time Frame: Up to 6 months after treatment beginning ]
    Parameter: findings in physical examinations
  • Safety and tolerability of the IMP [ Time Frame: Up to 6 months after treatment beginning ]
    Parameters: chosen laboratory parameters
  • Safety and tolerability of the IMP [ Time Frame: Up to 6 months after treatment beginning ]
    Parameter: ECG
  • Safety and tolerability of the IMP [ Time Frame: Up to 6 months after treatment beginning ]
    Parameter: adverse events
  • Humoral immuneresponse to the IMP [ Time Frame: Up to 6 months after treatment beginning ]
    Parameter: Serum concentration of anti-drug antibodies (ADA)
  • Pharmacokinetics of viral genomes [Vg] [ Time Frame: Up to 6 months after treatment beginning ]
    Parameter: Cmax in blood
  • Pharmacokinetics of viral genomes [Vg] [ Time Frame: Up to 6 months after treatment beginning ]
    Parameter: AUC in blood
  • Shedding of viral genomes [Vg] [ Time Frame: Up to 6 months after treatment beginning ]
    Parameter: Concentration of Vg in feaces
  • Shedding of viral genomes [Vg] [ Time Frame: Up to 6 months after treatment beginning ]
    Parameter: Concentration of Vg in urine
  • Shedding of viral genomes [Vg] [ Time Frame: Up to 6 months after treatment beginning ]
    Parameter: Concentration of Vg in saliva
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02653313 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: January 8, 2016)
  • Histo-immuno-pathological effects of the IMP in the hepatic metastasis [ Time Frame: Up to 2 months after treatment beginning ]
    Parameter: extent of tumor necrosis
  • Histo-immuno-pathological effects of the IMP in the hepatic metastasis [ Time Frame: Up to 2 months after treatment beginning ]
    Parameter: density of tumor infiltrating cells
  • Histo-immuno-pathological effects of the IMP in the hepatic metastasis [ Time Frame: Up to 2 months after treatment beginning ]
    Parameter: tissue content of cytokines
  • Histo-immuno-pathological effects of the IMP in the hepatic metastasis [ Time Frame: Up to 2 months after treatment beginning ]
    Parameter: tissue content of chemokines
  • Extent of virus replication in the hepatic metastasis [ Time Frame: Up to 2 months after treatment beginning ]
    Parameters: quantification of NS-1 protein in the metastatic tissue
  • Cellular immune response against viral proteins [ Time Frame: Up to 6 months after treatment beginning ]
    Parameter: ELISPOT
  • Cellular immune response against viral proteins [ Time Frame: Up to 6 months after treatment beginning ]
    Parameter: FACS
  • Clinical outcome [ Time Frame: Up to 6 months after treatment beginning ]
    Parameters: PFS, OS
  • Clinical outcome [ Time Frame: Up to 6 months after treatment beginning ]
    Parameter: Serum concentration of CA19-9
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Parvovirus H-1 (ParvOryx) in Patients With Metastatic Inoperable Pancreatic Cancer
Official Title  ICMJE A Non-controlled, Single Arm, Open Label, Phase II Study of Intravenous and Intratumoral Administration of ParvOryx in Patients With Metastatic, Inoperable Pancreatic Cancer
Brief Summary Investigation on safety, tolerability and efficacy of parvovirus H-1 (ParvOryx) in subjects suffering from metastatic, inoperable pancreatic cancer with at least one hepatic metastasis.
Detailed Description

Investigation on safety, tolerability and efficacy of parvovirus H-1 (ParvOryx) in subjects suffering from metastatic, inoperable pancreatic cancer with at least one hepatic metastasis.

Initially four equal doses of ParvOryx will be administered intravenously on four consecutive days. Seven to fourteen days after the first intravenous administration the drug will be injected directly in a hepatic metastasis of the pancreatic cancer.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Carcinoma, Pancreatic Ductal
Intervention  ICMJE Drug: Parvovirus H-1 (H-1PV)

Parvovirus H-1 administered at three increasing dose levels , according to the following schedule: i) 4 daily intravenous infusions of 10% of the total dose over 2 hours on 4 consecutive days, ii) direct injection of 60% of the total dose into a hepatic metastasis of the pancreatic cancer.

The total dose levels are: 1E09, 5E09 and 1E10 pfu.

Other Name: ParvOryx
Study Arms  ICMJE Experimental: ParvOryx
ParvOryx given intravenously on four consecutive days (day 1 to 4) and intrametastatic six to thirteen days thereafter (day 7, 10 or 14).
Intervention: Drug: Parvovirus H-1 (H-1PV)
Publications * Hajda J, Lehmann M, Krebs O, Kieser M, Geletneky K, Jäger D, Dahm M, Huber B, Schöning T, Sedlaczek O, Stenzinger A, Halama N, Daniel V, Leuchs B, Angelova A, Rommelaere J, Engeland CE, Springfeld C, Ungerechts G. A non-controlled, single arm, open label, phase II study of intravenous and intratumoral administration of ParvOryx in patients with metastatic, inoperable pancreatic cancer: ParvOryx02 protocol. BMC Cancer. 2017 Aug 29;17(1):576. doi: 10.1186/s12885-017-3604-y.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 8, 2016)
7
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE May 2018
Actual Primary Completion Date May 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Age at least 18 year,
  2. Ability to give informed consent,
  3. Histologically confirmed pancreatic ductal adenocarcinoma (PAD) with at least one measurable hepatic metastasis according to RECIST 1.1,
  4. Disease progression despite first line therapy (whatever chemotherapy regimen),
  5. Eligibility for second line chemotherapy with gemcitabine,
  6. ECOG performance scale 0 or 1,
  7. Consent for the sampling and investigations of biological specimens as scheduled by the trial protocol,
  8. Adequate bone marrow function: neutrophils >1.5 x 1E09/L, platelets >100 x 1E09/L, hemoglobin >9.0 g/dL,
  9. Liver function tests (LFT) within the following range: Bilirubin <3 x ULN (Upper Limit of Normal); ASAT and ALAT <5 x ULN,
  10. Adequate renal function: Creatinine <1.5 g/dL,
  11. Adequate blood clotting: aPTT <39 sec, INR <1.2,
  12. Normal thyroid function, i.e. TSH, fT3 and fT4 within the normal range (TSH: 0.4 - 4.0 mU/l, fT3: 2.0 - 4.2 ng/l, fT4: 8 - 18 ng/l)
  13. Negative serology for HIV, HBV and HCV,
  14. Negative Beta-HCG test in blood in woman of childbearing potential,
  15. Use of adequate contraception in both genders, i.e. use of double-effective method of contraception for the entire participation in the trial.

Exclusion Criteria:

  1. Eligibility for surgical treatment,
  2. Symptomatic cerebral, pulmonal, and/or osseous metastases,
  3. Peritoneal carcinosis,
  4. Liver cirrhosis,
  5. Splenectomy,
  6. Relevant respiratory impairment, corresponding to the grade IV or V of the MRC Breathlessness Scale (stops for breath after walking about 100 meters or after a few minutes on level ground, or too breathless to leave the house, or breathless when undressing),
  7. Positive anti-drug antibodies (ADAs) against ParvOryx,
  8. Hospitalization due to other conditions than the pancreatic cancer within the last 3 months,
  9. Chemotherapy within 2 weeks prior to the first administration of the IMP,
  10. Signs of active, systemic infection within 7 days prior to the study inclusion (clinical symptoms (cough, running nose, burning sensation while urinating, apparent skin or wound infection) and/or increase of fever and/or deterioration of infection-specific laboratory parameters beyond changes apparently driven by the underlying pancreatic cancer),
  11. Radiotherapy within 6 weeks prior to the study inclusion,
  12. Contraindications for CT,
  13. Known allergy to iodinated contrast media,
  14. Participation in another interventional trial within the last 30 days,
  15. Presumed contact with pregnant women and/or infants <12 months of age within two months after the first administration of the IMP.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Germany
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02653313
Other Study ID Numbers  ICMJE ParvOryx02
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Oryx GmbH & Co. KG
Study Sponsor  ICMJE Oryx GmbH & Co. KG
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Bernard Huber, Dr. Oryx GmbH & Co. KG
Principal Investigator: Guy Ungerechts, Prof. Dr. Dr. National Center for Tumor Diseases, Heidelberg
PRS Account Oryx GmbH & Co. KG
Verification Date March 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP